MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 3.00mm x 20mm emerge balloon catheter was advanced for dilation.However, during insertion of emerge balloon in lad together with 2.5x24 synergy xd stent into diagonal lesion, the balloon shaft fractured in mid section of the device.The device was removed and another 3.00mm x 20mm emerge balloon was used but the balloon shaft was bent.The device was also removed, and another of the same device was used and the procedure was completed successfully.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 3.00mm x 20mm emerge balloon catheter was advanced for dilation.However, during insertion of emerge balloon in lad together with 2.5x24 synergy xd stent into diagonal lesion, the balloon shaft fractured in mid section of the device.The device was removed and another 3.00mm x 20mm emerge balloon was used but the balloon shaft was bent.The device was also removed, and another of the same device was used and the procedure was completed successfully.No patient complications were reported.It was further reported that the shaft broke into two pieces.The device was still outside the guide when removed.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16726406
• Report Number: 2124215-2023-17125
• Device Sequence Number: 7190435
• Product Code: LOX
• UDI-Device Identifier: 08714729806349
• UDI-Public: 08714729806349
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2025
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0030783936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: EBU 3.5; GUIDE CATHETER: EBU 3.5; GUIDEWIRE: SAMURAI; GUIDEWIRE: SAMURAI
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Race: Black Or African American